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Eurofinsposted 2 months ago
Full-time • Mid Level
Cambridge, MA
10,001+ employees
About the position
We are seeking a highly skilled and motivated individual with in-depth knowledge of cell-based and potency assays and comfortable with troubleshooting. The Scientist will serve as SME for mRNA and gRNA potency assays to support several client programs.
Responsibilities
- Optimize, technical transfer, qualification, and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
- Acting as an SME resource for potency assays.
- Execution of complex GMP release and stability assays such as cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
- Author and review SOPs and technical reports.
- Work with cross-functional groups within the client environment to participate in various aspects of method development, transfer, process and product characterization, comparability, and investigations.
- Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
Requirements
- Strong background in cell culture and experience working with cell lines and primary human cells.
- Experience with functional, or potency assay transfer and execution in a GMP laboratory.
- Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, flow cytometry, ELISA, and NGS.
- Experience using data analysis software including JMP.
- Knowledge of ICH/USP guidelines.
- Bachelor’s degree with 3-8 years of experience, Master’s degree with 2-5 years of experience, or PhD degree with 0-1 years of experience.
- Must have experience with potency assay execution.
- Team player with excellent oral and written communication skills.
- Independently motivated, detail-oriented, and excellent problem-solving abilities.
Benefits
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
